Copper

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD Guideline 406 and EU Method B.6 The test material has no batch number and no information on purity nor particle size distribution.

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

study was performed (ad assesed) before the 2016 change in the ECHA Guidance

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

Source: sighting animals were received from David Hall Limited, Burton-on-trent, Staffordshire, UK. Main study animals were received from Harlan UK Ltd., Blackthorn, Bicester, Oxon, UK.
At the start of the main study the animals weighed 340 to 436g and were approximately eight to twelve weeks old.

6 sighting animals, 10 test animals and 5 control animals

Route:

intradermal

Vehicle:

arachis oil

Concentration / amount:

Intradermal induction: 0.1 % w/w in arachis oil BP.
Topical induction: 50% w/w in arachis oil BP
Topical challenge: 50 and 25% w/w in arachis oil BP

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Concentration / amount:

Intradermal induction: 0.1 % w/w in arachis oil BP.
Topical induction: 50% w/w in arachis oil BP
Topical challenge: 50 and 25% w/w in arachis oil BP

No. of animals per dose:

10

Details on study design:

Day 0: intradermal induction
Day 7: topical induction
Day 21: topical challenge

scoring: 24 and 48h after challenge

Positive control substance(s):

yes

Remarks:

2-Mercaptobenzothiazole

Positive control results:

Non-concurrent positive control studies with 2 -mercaptobenzothiazole, showing 90 -100 % incidence of sensitisation, confirmed the sensitivity of this assay

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0 % w/w

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no skin reactions were noted at the challenge sites of the control group animals

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no skin reactions were noted at the challenge sites of the control group animals.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0% w/w

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no skin reactions were noted at the challenge sites of the control group animals

Remarks on result:

other: see Remark

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no skin reactions were noted at the challenge sites of the control group animals.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50% w/w

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no skin reactions were noted at the challenge sites of the test group animals

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reactions were noted at the challenge sites of the test group animals.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

50% w/w

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no skin reactions were noted at the challenge sites of the test group animals

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reactions were noted at the challenge sites of the test group animals.

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material corresponds to the composition of “coated copper flakes” . Under the conditions of this test, copper powder produced a 0% (0/10) sensitisation rate. The test material did not meet the criteria for classification as a sensitiser by skin contact according to labelling regulations outlined in Annex VI of Commission Directive 2001/59/EC

Executive summary:

The test material identity was not provided in details. Considering the information from the reports on the same material, the tested material falls in the composition category of "coated copper flakes", consistent with a biocidal product use (PBD notification was the reason for doing the test).

Under the conditions of this test, the test material produced a 0% (0/10) sensitisation rate.

Copper powder did not meet the criteria for classification as a sensitiser by skin contact according to labelling regulations outlined in Annex VI of Commission Directive 2001/59/EC

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Available animal data on the skin sensitisation properties of copper (II) oxide and copper coated flakes have been considered against EU classification criteria as contained in Annex VI of Directive 67/548/.  The available animal data do not meet the criteria requiring these substances to be classified for skin sensitisation. Considering the lower solubility and bioaccessability of copper powders compared to copper oxides and copper flakes, the data are read-across to copper (powders and massive forms) do not require classification for skin sensitisation.

With regard to sensitisation by inhalation, in the absence of relevant human or animal data, there is no basis for classification of copper substances covered by this Risk Assessment for respiratory sensitisation.

Migrated from Short description of key information:
Several high quality criteria studies (reliability 1 or 2) on several copper compounds and copper are available from the VRAR (2008). The data on coated copper flakes and copperoxide were retained for the CSR
The VRAR, 2008 provides additional lower quality studies as well as studies specific to other soluble copper compounds. If not pivotal to this copper REACH dossier, they are described in the copper VRAR (2008) but not further

Justification for selection of skin sensitisation endpoint:
Several studies used in WoE.
The studies, retained in weight of evidence approach, were already evaluated by competent authorities on existing substances and biocides